Status:
NOT_YET_RECRUITING
A Study to Evaluate the Feasibility of a Physiologic Biomarker to Assess Pain and Other Sensory Problems Using Pupillometry in Participants With Neurofibromatosis Type 1 (NF1)
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Neurofibromatosis Type 1
Eligibility:
All Genders
1-120 years
Phase:
NA
Brief Summary
Background: Neurofibromatosis type 1 (NF1) is a genetic condition that causes tumors to grow along the nerves in the skin, brain, and other parts of the body. People with NF1 often have pain and may ...
Detailed Description
Background: * Chronic pain is a common and often debilitating symptom of neurofibromatosis 1 (NF1) that is related to multiple tumor (e.g., plexiform neurofibromas; PN) and non-tumor (e.g., headaches...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- History of clinical or genetic diagnosis of NF1 as per the 2021 revised diagnostic criteria
- Age \>= 1 year
- At least one digit (finger or toe) without open wounds for application of the device
- Individuals must understand English or Spanish
- Individuals who are \< 18 years must have a caregiver willing to help the child engage in study procedures, assist with fitting the AlgometRx Nociometer (Registered Trademark) device, and complete the observer reported (ObsRO) measures. Note: the caregiver of a child participant \>= 5 years old must be able to understand English or Spanish, the caregiver of a child participant 1-4 years old must be able to understand English (to help complete the observational pain measure for the younger children that is only available in English)
- Ability of individual or parent/guardian to understand and the willingness to sign a written informed consent document
- EXCLUSION CRITERIA
- History of eye pathology which precludes pupillometry, such as problems with pupillary reflex, blindness or inability to open at least one eye fully for evaluation
- Individuals with chronic use of medication that specifically affects their pupillary response, such as atropine-containing eye drops
- Uncontrolled intercurrent illness evaluated by medical history that would potentially increase in risk of participant
Exclusion
Key Trial Info
Start Date :
January 14 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06507748
Start Date
January 14 2026
End Date
May 1 2026
Last Update
January 9 2026
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892